The study will assess tumor response after four weeks of intra-tumoral injections of TNFerade plus concomitant radiation therapy in 29 patients with stage III or IV metastatic melanoma who are ineligible for curative surgery or unlikely to benefit from other treatment options.
Patients will be evaluated two months after the completion of therapy and followed for three years thereafter.
“This study expands the TNFerade development program into a potential indication where there is a significant medical need,” said Dr Thomas Davis, chief medical officer of GenVec. “This is an important study as it also provides a good clinical setting for us to test whether TNFerade can induce the body’s immune system to fight systemic cancer.”
In a phase I trial in patients with solid tumors, three patients with stage IV metastatic melanoma had complete local response and prolonged disease-free survival after local TNFerade lesion injection plus concomitant radiation; two of those patients remain disease-free approximately four years after treatment. This compares to the average survival rate of less than 2 years for patients with stage IV metastatic melanoma.
GenVec is developing TNFerade for use in combination with radiation and/or chemotherapy for the treatment of various cancers.